Kornimate/medical-research-clean huggingface dataset:
ketamine anesthesia in electroconvulsive therapy

Conditions: Depression

Summary: does the use of ketamine as the anesthetic medication in electroconvulsive therapy (ect) accelerate the antidepressant effect of ect? the study hypothesis was that depressed subjects receiving ect with ketamine as the anesthetic agent would demonstrate a faster rate of improvement, defined as lower depression ratings after the second ect than depressed patients receiving ect with the usual anesthetic agent.

there are several drugs available to induce anesthesia for electroconvulsive therapy (ect), a psychiatric treatment for major depressive illness. the most commonly utilized of these include methohexital, thiopental, etomidate, and propofol. recently, there has been interest in the use of ketamine in sub-anesthetic doses to treat major depressive illness. in this randomized, blinded trial, depressed subjects scheduled to be treated with ect were anesthetized with either ketamine or methohexital at doses of approximately 1.0 mg/kg for each drug. patients received the same drug for up to six of their ect treatments. outcome measures included assessments of depressive severity, cognition, post-anesthesia side effects, and hemodynamics. subjects were to be followed with as long as they were receiving inpatient ect treatments. the number of treatments was determined entirely by their primary psychiatric team, also blind to anesthetic, as per usual care. in other words, this study did not determine when to terminate the ect course.

Eligibility criteria:
inclusion criteria: * diagnosis of depression, either unipolar or bipolar * subjects receiving ect at the mayo clinic exclusion criteria: * subjects not giving their own consent to ect * subjects with schizophrenia, schizoaffective disorder, or dementia * subjects diagnosed with a major neurological disorder such as epilepsy, parkinson disease, multiple sclerosis, or a neurodegenerative dementia.

Keywords: depression electroconvulsive therapy ketamine methohexital
treatment of newly diagnosed ovarian cancer with antioxidants

Conditions: Ovarian Cancer

Summary: the purpose of this study is to try and understand if there is added benefit or increased harm when antioxidant nutritional supplements are added to traditional chemotherapy in the treatment of ovarian cancer.

the subjects are randomized to 2 study groups. group 1 receives standard chemotherapy prescribed by the cancer doctor (carboplatin and paclitaxel)with a possible choice to extend chemotherapy for up to an additional 12 months. group 2 receives standard chemotherapy in the same manner as group 1. in addition, they receive 12 months of oral or iv nutritional supplements.

Eligibility criteria:
inclusion criteria: * histologically confirmed carcinoma of the ovary stage iii or iv * measurable or assessable disease * drug refractory ovarian cancer * must be 18 years of age or must have parental consent to enroll in the study * must be ambulatory exclusion criteria: * evidence of significant psychiatric disorder by history or exam * consumption of excess alcohol (more than 4 of any of the following per day: 30 ml distilled spirits, 340 ml beer, or 120 ml wine) or recreational drugs * tobacco use * prior treatment with an investigational drug, chemo, radiation therapy, or hormonal therapy within the preceeding month * pregnancy
ga yaz acne in china phase iii

Conditions: Acne Vulgaris

Summary: the purpose of this study is to evaluate the efficacy and safety of yaz (drospirenone 3 mg / ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne vulgaris over 6 treatment cycles.


Eligibility criteria:
inclusion criteria: * women of age 14-45 years * \>1 year post-menarche with moderate acne vulgaris who have no known contraindications to combined oral contraceptives * otherwise healthy, except for the presence of moderate acne * smokers up to a maximum age of 30 (inclusive) at inclusion exclusion criteria: * pregnancy, lactation (less than three menstrual cycles since delivery, abortion, or lactation before start of treatment) * obesity (body mass index \> 30 kg/m2) * hypersensitivity to any ingredient of the study drug * any disease or condition that may worsen under hormonal treatment

Keywords: moderate acne vulgaris oral contraceptive female
bva-200 vs bva-100 validation study

Conditions: Heart Failure; High Blood Pressure; High Cholesterol; Anemia; Diabetes; Thyroid Diseases; Kidney Diseases; Clotting Disorder; Trauma; Other Disease

Summary: the proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the fda-cleared daxor bva-100 device to the daxor bva-200 device. data from this study may be pooled with data from studies with similar design conducted at other sites, for the purposes of an fda medical device submission.

measurements of human blood volume will be made via the indicator dilution method, using gamma counter readings of the concentration of i-131 in a subject's blood sample taken after radio-iodinated human serum albumin (hsa) has been injected into the bloodstream via venous access. each subject receiving an injection will have five separate blood samples taken, which will be analyzed separately. each of the five measurements will be conducted in duplicate with the bva-100 instrument and the bva-200 instrument. sufficient blood will be withdrawn at each phlebotomy to permit such duplicate measurement. subjects will be enrolled who have been prescribed a blood volume procedure using the bva-100, as a result either of their ordinary diagnostic care or of their participation in another study that uses blood volume measurement. subjects will be adults under treatment for conditions normally associated with the need for volume assessment, such as heart failure, or scheduled to receive bva-100 measurement as part of another study. an effort will be made to ensure a range of ages and a balance of the sexes. subjects will be enrolled and consented sequentially. the university of tennessee medical center site will document any patient who is not enrolled in the study sequentially and the reason why or who declines enrollment. demographics of patients not enrolled will be collected to permit identification of any trends in non-enrollment. we do not anticipate any sequential patient not being offered the opportunity to participate in order to assure that there is no bias in selection of patients ("all-comers").

Eligibility criteria:
inclusion criteria: 1. age: over18 years; 2. able and willing to provide informed written consent. 3. subjects will be enrolled who have been prescribed a blood volume procedure using the bva-100, as a result either of their ordinary diagnostic care or of their participation in another study that uses blood volume measurement. subjects will be adults under treatment for conditions normally associated with the need for volume assessment, such as heart failure, or scheduled to receive bva-100 measurement as part of another study. exclusion criteria: 1. pregnant women or nursing mothers. 2. women of childbearing potential not using adequate birth control methods. 3. known hypersensitivity to iodine or eggs. 4. other clinical basis for precluding the use of radioactive materials. 5. has previously been enrolled in, and completed, the study.

Keywords: blood volume point of care fluid management diagnostic
multicenter study of iloprost inhaled in pulmonary hypertension after repair of congenital heart diseases (chd)

Conditions: Pulmonary Hypertension

Summary: this study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. it was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.

primary objectives: 1. to evaluate the effect of iloprost inhaled on postoperative ph after biventricular repair for chd. 2. to verify the benefits of iloprost inhaled in improving the hemodynamics after biventricular repair for chd. secondary objectives: 1. to investigate the preventive effect of iloprost inhaled on the life-threatening phc occurring immediately after complex congenital heart surgery or occurring just after weaning off cardiopulmonary bypass. 2. to explore the potential of iloprost inhaled to reduce the early mortality after phc and to decrease the use of ecmo/vad.

Eligibility criteria:
inclusion criteria: * chd children who have associated ph risk factors and have accepted biventricular repair * pp/ps \>= 0.75 (before surgery) or pp/ps \>= 0.5 (after surgery) exclusion criteria: * severe mitral stenosis * obstructive drainage of pulmonary veins * platelet count \< 50,000,000,000/l \& obvious bleeding

Keywords: pulmonary hypertension, pulmonary hypertensive crisis
study of phosphorylated metabolism profile as predictive biomarker of cognitive decline in memory complaint.

Conditions: Memory Complaint; Alzheimer Disease; Phosphorylated Metabolism Profile; Magnetic Resonance Spectroscopy

Summary: alzheimer disease is a frequent disease in the late ages that results in global alteration of cognitive functions. in which memory complaint can be isolated in the early stages. physiopathology of neuronal degenerescence in alzheimer disease is complex, two main histological lesions are known, amyloid plaques and neurofibrillar tangles. beyond the histological knowledge, alterations of neuronal metabolism are described such as oxydative phosphorylation and glycolytic pathway. these metabolism alterations are involved in neuronal death. multi-nucleus magnetic resonance spectroscopy is a non-invasive non-irradiant imagery technique already used in routine. this technic allows the phosphoenergetic pool assessment, that inform about cellular metabolism. the aim of the study is to explore the phosphorylated metabolism patterns as predictive biomarkers of cognitive decline in patients with a memory complaint diagnosed.


Eligibility criteria:
inclusion criteria: 1. memory complaint, leading to a medical visit at the centre mémoire de ressources et de recherche (cmrr) of poitiers, and for which an mri is needed in routine exploration. 2. age inferior at 90 years old 3. mini mental state examination (mmse) score between 20 and 30 4. patient without guardianship measure, without restricted liberty. 5. patient who benefits from social security exclusion criteria: 1. vascular, tumor, inflammatory pathology diagnosed by mri 2. other diagnosed neurodegenerative disease than alzheimer disease 3. other non neurodegenerative neurological disease 4. vital risk at short term 5. severe and uncontrolled psychiatric disease
computer adaptation of screening, brief met intervention to reduce teen drinking

Conditions: Alcohol Abuse; Tobacco Use Disorder; Substance Use

Summary: the goal of this project is to evaluate the feasibility, acceptability, and effect size of a new computerized motivational enhancement therapy (cmet) intervention for alcohol-involved adolescents in primary care.

the study aims are to: 1. assess cmet feasibility and acceptability and estimate its effect size on underage drinking. hypothesis: among 14- to 20-yr-old primary care patients, those receiving cmet will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, than those receiving treatment as usual. 2. estimate effect sizes for tobacco, cannabis, and other drug use, and other substance-related risks and outcomes including substance-related driving/riding, and experience of substance-related problems. 3. identify potential moderators and mediators of cmet's effect.

Eligibility criteria:
inclusion criteria: * 14- to 20- yr-olds * arriving for routine care to one of our participating pediatric practices (lexington pediatrics, lexington, ma; east boston community health center, longwood pediatrics, tufts medical center adolescent clinic, boston, ma; cambridge health alliance dept. of pediatrics, cambridge, ma) * any alcohol use days in the past 90 days, * have an email address and internet access at home, school, or library * provide informed assent/consent. exclusion criteria: * unable to read or understand english, * living away at college at the time of the recruitment visit, * not available for computer/telephone follow-ups, * judged by the provider to be medically or emotionally unstable at the time of the visit.

Keywords: alcohol abuse substance use tobacco use disorder motivational enhancement therapy adolescents
tolerability of quinagolide in a dose-titration regimen in oocyte donors at risk of developing ovarian hyperstimulation syndrome

Conditions: Ovarian Hyperstimulation Syndrome

Summary: assess the tolerability of quinagolide 200 μg/day in a dose-titration regimen in oocyte donors undergoing controlled ovarian hyperstimulation and at risk of developing ohss secondary objectives estimate the effects of a quinagolide dose-titration regimen compared to placebo in peritoneal fluid accumulation, incidence of ascites, ohss symptoms and clinical laboratory parameters of haemoconcentration


Eligibility criteria:
inclusion criteria: 1. signed informed consent form, prior to screening evaluations 2. in good physical and mental health 3. pre-menopausal females between the ages of 21-34 years (both inclusive) at the time of randomisation 4. body mass index (bmi) between 18 and 29 kg/m2 (both inclusive) 5. oocyte donor currently undergoing a controlled ovarian hyperstimulation cycle for assisted reproductive technologies (art) 6. antral follicle count ≥ 20 exclusion criteria: 1. any exclusion criteria for oocyte donation 2. known clinically significant systemic disease (e.g., insulin dependent diabetes) 3. known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study 4. undiagnosed vaginal bleeding 5. known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus 6. malformations of the sexual organs incompatible with pregnancy 7. positive pregnancy test prior to start of stimulation 8. treatment with other dopamine agonists (atc code n04bc) or dopamine antagonists (atc code n05a) within 2 months prior to randomisation 9. treatment with any hormonal therapy (except for thyroid medication and oral contraceptives and except that routinely used as part of the controlled ovarian hyperstimulation cycle), anti-psychotics (atc code n05a), anti-depressants (atc code n06), anxiolytics (atc code n05b), hypnotics and sedatives (atc code n05c) or continuous use of prostaglandin inhibitors (non-steroid anti-inflammatory drugs (nsaids), including aspirin) within 2 weeks prior to randomisation 10. known hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption 11. known history of psychotic disorders 12. hypotension, orthostatic hypotension or recurrent syncope within 6 months prior to randomisation 13. ongoing treatment of hypertension 14. known previous poor tolerability to dopamine agonists 15. known impaired hepatic or renal function 16. current or past (12 months prior to randomisation) abuse of alcohol or drugs, and/or current (last month prior to randomisation) use of alcohol (more than 14 units per week) 17. current or past (3 months prior to randomisation) smoking habit of more than 20 cigarettes per day 18. history of chemotherapy (except for gestational conditions) or radiotherapy 19. use of any investigational drug during 3 months prior to randomisation 20. previous participation in the study 21. hypersensitivity to the active substance or to any of the excipients
multifunctional substrate for early detection of oxidative stress susceptibility and application to parkinson's disease

Conditions: Parkinson's Disease; Oxidative Stress

Summary: the proposed work is based on the detection of a novel molecule for sensitivity to oxidative stress in humans in venous blood

since alterations in mitochondrial functions in platelets and lymphocytes have been detected in parkinson's disease we plan to monitor the metabolism a a new molecule (ltg) in the blood samples of parkinson's disease patients and compare them to controls. we shall use 10 cc of venous blood and analyze serum, white blood cells and platelets. we shall not extract nor use dna.the main purpose is to develop a marker for parkinson's disease in venous blood.

Eligibility criteria:
inclusion criteria: parkinson's disease healthy control - exclusion criteria: none -

Keywords: parkinson's disease oxidative stress marker
ablative chemoembolization for unresectable and large hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: the objective of this study is to study the safety and tumor response of ace for large hcc.

transarterial treatment has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic hepatocellular carcinoma not eligible for surgical resection, transplantation, or local ablative therapy. among the patient group with intermediate tumor stage, in which the tumor dimension exceeds 10cm, the treatment outcome of conventional chemoembolization (ctace), chemoembolization using drug eluting beads (deb-tace) and radioembolization using yttrium 90 is generally unsatisfactory. some would consider hcc of size \>10cm a relative contraindication for ctace because of the poor treatment outcome. however, there is no better alternative treatment for local control of these tumors. ablative chemoembolization (ace) using lipiodol-ethanol and anhydrous cisplatin has been found to be highly effective for local control of hcc as compared to ctace in a case-control study. it is hypothesized that ace is safe and effective for local control of large hcc of size \>10cm.

Eligibility criteria:
inclusion criteria: 1. signage of a written informed consent 2. age above 18 years 3. hcc unsuitable for resection 4. child-pugh a or b cirrhosis 5. eastern cooperative oncology group performance score 0 or 1 6. no previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy), 7. hcc diagnosed by typical enhancement patterns on cross sectional imaging or histology. 8. no extra-hepatic involvement on non-enhanced ct thorax and triphasic contrast enhanced ct abdomen. 9. no invasion of portal vein or hepatic vein 10. massive expansive tumor morphology with measurable lesion on ct (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions) 11. total tumor mass \< 50% liver volume 12. size of any individual tumor \>10cm in largest dimension exclusion criteria: 1. history of acute tumor rupture presenting with hemo-peritoneum 2. biliary obstruction not amenable to percutaneous or endoscopic drainage 3. child-pugh c cirrhosis 4. history of hepatic encephalopathy 5. intractable ascites not controllable by medical therapy 6. history of variceal bleeding within last 3 months 7. serum total bilirubin level \> 50 umol/l 8. serum albumin level \< 25g/l 9. inr \> 1.7 10. serum creatinine level \> 150 mmol/l. 11. infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules) 12. arterio-portal venous shunt affecting \>1 hepatic segment on ct 13. arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on ct
effect of soy on hdl-c function, central blood pressure, and arterial stiffness

Conditions: Cardiovascular Disease

Summary: the purpose of the proposed pilot study is to evaluate the effects of a soy protein isolate with naturally occurring isoflavones on the properties of hdl-c (total hdl-c, hdl particle size and hdl function), central blood pressure, and indices of arterial stiffness.

the investigators propose to conduct a randomized three-period, crossover study to evaluate the effect of soy protein supplementation on hdl function. to ensure that there are no effects of treatment order on outcome measures, subjects will be randomized to a treatment sequence. healthy males and females (n = 20; 35 to 60 years of age) with systolic blood pressure greater than 120 mm hg and/or diastolic blood pressure greater than 80 mm hg will be recruited for this study. subjects will undergo 3 treatment periods in random order. these treatment periods will include: a) 25 g/d soy protein powder; b) 50 g/d soy protein powder; c) 0 g/d protein powder (control). each treatment will be provided for 6 weeks separated by a 2-week break between treatment periods. all subjects will be encouraged to maintain body weight and physical activity levels during the study.

Eligibility criteria:
inclusion criteria: * male and female * 35-60 years old,with * systolic blood pressure greater than 120 mm hg * diastolic blood pressure greater than 80 mm hg * bmi within 18-39 kg/m2 , * non smokers with * no inflammatory diseases and * not taking medication for high cholesterol, blood pressure, or glucose control exclusion criteria: * under 35 years of age or over 60 years old * systolic blood pressure \<120 or diastolic blood pressure \<80 * smoker * inflammatory disease * bmi outside of 18-39kg/m2 range * taking medication * refusal to discontinue any other supplement use

Keywords: soy hypertension hdl-c cholesterol efflux cardiovascular disease
combined gut-brain therapy for children with autism

Conditions: Autism Spectrum Disorder; Functional Gastrointestinal Disorders; Neurodevelopmental Disorders; Anxiety

Summary: clinical issue: children with autism spectrum disorder (asd) are four times more likely to suffer with functional gastrointestinal disorders (fgids) than their neurotypical peers. the presence of fgids are linked to increased undesirable behaviour and asd severity. current behavioural approaches for asd therapy do not alleviate the high comorbidity of fgids within this population. background: dysfunction of the microbiome-gut-brain (mgb) axis has been implicated in pathogenesis of both asd and fgids. probiotics and prebiotics can modulate the gut microbiome and research has shown efficacy at improving gastrointestinal (gi) symptoms in children with asd and neurotypical (nt) children with fgids. gut-directed hypnotherapy (gdh) has shown utility in treating fgids in nt children and adults but has not yet been trialed in children with asd. targeting therapies to address the dysfunction of the bidirectional mgb axis will likely be more effective than either brain/behavioural or gut-based therapy alone. hypothesis: a synbiotic (prebiotic + probiotic mixture) with combined gdh will be more effective than a synbiotic alone at reducing gi symptoms in children with asd aged 5.00 to 10.99 years over a 12-week period.


Eligibility criteria:
inclusion criteria: 1. aged 5.00 years to 10.99 years 2. a confirmed diagnosis of asd or pervasive developmental disorders (pdd) including autistic disorder, asperger's disorder (as); pdd not otherwise specified (pdd-nos); and atypical autism. 3. a diagnosis of a functional gastrointestinal disorder (fgid) by a gastroenterologist or a score of three and above on the six-item gastrointestinal severity index (6-gsi). accepted fgids include diarrhoea, constipation, bloating, abdominal pain or irritable bowel syndrome (ibs). exclusion criteria: 1. non-verbal children and/or those with severe cognitive impairment 2. confirmed diagnosis of inflammatory bowel disease, coeliac disease, or current infection of the gi tract. 3) any other medication, supplement or conditions which can impact the gut microbiome, including: * antibiotics or antifungals in the last month * probiotic or prebiotic supplements in the last two weeks * immunocompromised or severely ill * bipolar, schizophrenia, personality disorders * diabetes mellitus or an eating disorder